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To study the safety and performance of the Shockwave Medical Lithoplasty System in subjects to demonstrate that the Shockwave device can safely and effectively deliver localized shockwave energy for balloon dilatation of calcified, stenotic, infrainguinal peripheral arteries.
Shockwave Medical, Inc. intends to conduct a prospective, single-arm, multi-center, clinical study designed to evaluate the safety and performance of the Shockwave Lithoplasty System in subjects with moderate to heavily calcified peripheral arteries with 3.50mm to 7.0mm reference vessel diameter at the target site. The Shockwave Lithoplasty System is indicated to generate sonic shockwave energy within the target treatment site and disrupt calcium within the lesion to allow for subsequent dilation of a peripheral artery stenosis using low balloon pressure. Up to thirty-five (35) subjects will be enrolled and treated with Lithoplasty to yield thirty (30) evaluable subjects complete the study assuming a 15% lost to follow-up rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lithoplasty Treatment | Experimental | Shockwave Lithoplasty System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shockwave Lithoplasty System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of New-onset Major Adverse Events (MAE) | Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting. | 30 days |
| Procedural Success: | The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation. | Day of Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation. | Day of Procedure |
| Clinical Success: |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoint | The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate. | Day of Procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Zeller, MD | Bad Krozingen | Principal Investigator |
| Andrew Holden, MD | Auckland City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universitaet Graz | Graz | Graz | 8036 | Austria | ||
| Department of Angiology - Universitats Herzzentrum Freiburg |
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Three investigational sites in Austria and New Zealand participated in the study. Between January 2014 and September 2014, a total of 35 subjects and 39 lesions of the superficial femoral and popliteal arteries were enrolled in the Full Analysis Cohort of the study and treated with the investigational device.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lithoplasty Treatment | All subjects were treated with the Shockwave Medical Peripheral Lithoplasty System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lithoplasty Treatment | Shockwave Medical Peripheral Lithoplasty System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite of New-onset Major Adverse Events (MAE) | Need for emergency surgical revascularization of target limb. Unplanned target limb amputation (above the ankle). Symptomatic thrombus or distal emboli, defined as clinical signs or symptoms of thrombus or distal emboli detected in the treated limb in the area of the treated lesion, or distal to the treated lesion, after the index procedure or noted angiographically, and requiring mechanical or pharmacologic means to improve flow. Perforations and dissections of grade D or greater that require an intervention to resolve, including bail-out stenting. | Posted | Number | participants | 30 days |
|
through 30 days and 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lithoplasty Treatment | Shockwave Medical Peripheral Lithoplasty System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Need for emergency surgical revascularization of target limb | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gheda Sahyun, Director of Clinical Affairs | Shockwave Medical, Inc. | 510-624-9073 | gsahyun@shockwavemedical.com |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events. |
| Day of Procedure |
| Technical Success: | The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel. | Day of Procedure |
| Freedom From Major Adverse Events | Freedom from Major Adverse Events at 30 days. | 30 days |
| Freedom From Target Lesion Revascularization (TLR) | Freedom from Target Lesion Revascularization (TLR) at 30 days | 30 days |
| Patency | Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5). | 30 days |
| Ankle Brachial Index (ABI) | Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. | Baseline and 30 days |
| Rutherford Clinical Category | Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant. | Baseline and 30 days |
| Freedom From Major Adverse Events | Freedom from Major Adverse Events at 6 months | 6 months |
| Freedom From Target Lesion Revascularization (TLR) | Freedom from Target Lesion Revascularization (TLR) at 6 months | 6 months |
| Patency | Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5). | 6 months |
| Ankle Brachial Index (ABI) | Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. | Baseline and 6 months |
| Rutherford Clinical Category | Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant. | Baseline and 6 months |
| Bad Krozingen |
| Baden-Wurttemberg |
| 79189 |
| Germany |
| Auckland City Hospital | Auckland | Auckland | 92024 | New Zealand |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Procedural Success: | The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive Percutaneous Transluminal Angioplasty therapy) as assessed by quantitative angiography via core lab evaluation. | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted. | Posted | Number | 95% Confidence Interval | percentage of lesions | Day of Procedure | lesions | lesions |
|
|
|
| Secondary | Device Success | The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (without adjunctive percutaneous transluminal angioplasty therapy) as assessed via quantitative angiography via core lab evaluation. | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment attempted | Posted | Number | 95% Confidence Interval | percentage of lesions | Day of Procedure | lesions | lesions |
|
|
|
| Secondary | Clinical Success: | The ability of the Shockwave Medical Lithoplasty System to achieve a post-Shockwave residual diameter stenosis of <50% (with or without adjunctive percutaneous transluminal angioplasty therapy) as assessed by the investigator via visual estimate and freedom from procedural major adverse events. | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted | Posted | Number | 95% Confidence Interval | percentage of participants | Day of Procedure |
|
|
|
| Secondary | Technical Success: | The ability of the Shockwave Medical Lithoplasty System to delivery ShockWave treatment to the desired location in the target vessel. Up to two Shockwave Medical Lithoplasty Systems maybe used to complete treatment in the target vessel. | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted | Posted | Number | 95% Confidence Interval | percentage of lesions | Day of Procedure | lesions | lesions |
|
|
|
| Secondary | Freedom From Major Adverse Events | Freedom from Major Adverse Events at 30 days. | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted | Posted | Number | percentage of participants | 30 days |
|
|
|
| Secondary | Freedom From Target Lesion Revascularization (TLR) | Freedom from Target Lesion Revascularization (TLR) at 30 days | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed | Posted | Number | percentage of lesions | 30 days | lesions | lesions |
|
|
|
| Secondary | Patency | Vessel patency at 30 days by Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of ≥2.5). | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted. Due to device malfunctions, one subject received partial treatment. To provide a more accurate account of actual device usage, the subject was omitted from the analysis of device usage only. | Posted | Number | 95% Confidence Interval | percentage of lesions | 30 days | lesions | lesions |
|
|
|
| Secondary | Ankle Brachial Index (ABI) | Change in Ankle Brachial Index (ABI) of the target limb at 30 days. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed. Four subjects were not included in the analysis because ABI could not be measured due to non-compressible disease that inhibited accurate ABI measurement. | Posted | Mean | 95% Confidence Interval | change in ABI score from baseline | Baseline and 30 days |
|
|
|
| Secondary | Rutherford Clinical Category | Change in Rutherford Clinical Category (RCC) at 30 days. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant. | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed | Posted | Mean | 95% Confidence Interval | change in RCC from baseline | Baseline and 30 days |
|
|
|
| Secondary | Freedom From Major Adverse Events | Freedom from Major Adverse Events at 6 months | Full Analysis Cohort - All subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was attempted | Posted | Number | percentage of participants | 6 months |
|
|
|
| Secondary | Freedom From Target Lesion Revascularization (TLR) | Freedom from Target Lesion Revascularization (TLR) at 6 months | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed | Posted | Number | percentage of lesions | 6 months | lesions | lesions |
|
|
|
| Secondary | Patency | Vessel patency at 6 months at Doppler Ultrasound defined as freedom from greater than 50% restenosis (as assessed by Duplex ultrasound peak systolic velocity ratio of =2.5). | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed | Posted | Number | 95% Confidence Interval | percentage of lesions | 6 months | lesions | lesions |
|
|
|
| Secondary | Ankle Brachial Index (ABI) | Change in Ankle Brachial Index (ABI) of the target limb at 6 months. The Ankle Brachial Index (ABI) is the systolic pressure at the ankle, divided by the systolic pressure at the arm. | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Lithoplasty treatment was successfully completed | Posted | Mean | 95% Confidence Interval | Ankle Brachial Index | Baseline and 6 months |
|
|
|
| Secondary | Rutherford Clinical Category | Change in Rutherford Clinical Category (RCC) at 6 months. RCC identifies three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Grade I includes Category 0 - Asymptomatic, Category 1 - Mild claudication, Category 2 - Moderate claudication, and Category 3 - Severe claudication. Grade II includes Category 4 - Ischemic rest pain and Category 5 - Minor tissue loss. Grade III includes Category 6 - Ulceration or grangrene. Change of at least 2 categories considered statistically significant. | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed | Posted | Mean | 95% Confidence Interval | Rutherford Clinical Category | Baseline and 6 months |
|
|
|
| Other Pre-specified | Exploratory Endpoint | The clinical protocol provided for an Exploratory Secondary Endpoint to assess the ability of the device to achieve ≤30% residual stenosis without adjunctive PTA as assessed by the investigator via visual estimate. | Per-Protocol Cohort - the group of subjects who were enrolled in the study and where delivery of the Shockwave Medical Peripheral Lithoplasty treatment was successfully completed | Posted | Number | percentage of lesions | Day of Procedure | lesions | lesions |
|
|
|
| 0 |
| 35 |
| 19 |
| 35 |
| Unplanned target limb amputation (above the ankle) | Surgical and medical procedures | Systematic Assessment |
|
| Symptomatic thrombus or distal emboli | Injury, poisoning and procedural complications | Systematic Assessment | clinical signs or symptoms of thrombus or distal emboli detected in treated limb in area of treated lesion or distal to treated lesion after index procedure or noted angiographically and requiring mechanica or pharmacological means to improve flow |
|
| Perforations and dissections of grade D or greater that require an intervention to resolve | Injury, poisoning and procedural complications | Systematic Assessment | includes bail-out stenting |
|
| Angina pectoris | Cardiac disorders |
|
| Cardiac failure congestive | Cardiac disorders |
|
| Coronary artery disease | Cardiac disorders |
|
| Coronary artery stenosis | Cardiac disorders |
|
| Ocular hyperaemia | Eye disorders |
|
| Photokeratitis | Eye disorders |
|
| Abdominal pain lower | Gastrointestinal disorders |
|
| Large intestine polyp | Gastrointestinal disorders |
|
| Vessel puncture site haematoma | General disorders |
|
| Cholecystitis acute | Hepatobiliary disorders |
|
| Bronchitis | Infections and infestations |
|
| Urinary tract infection | Infections and infestations |
|
| Contusion | Injury, poisoning and procedural complications |
|
| Joint injury | Injury, poisoning and procedural complications |
|
| Peripheral artery restenosis | Injury, poisoning and procedural complications |
|
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications |
|
| Arthralgia | Musculoskeletal and connective tissue disorders |
|
| Back pain | Musculoskeletal and connective tissue disorders |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
|
| Carpal tunnel syndrome | Nervous system disorders |
|
| Dizziness | Nervous system disorders |
|
| Memory impairment | Nervous system disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Endarterectomy | Surgical and medical procedures |
|
| Haematoma | Vascular disorders |
|
| Peripheral artery dissection | Vascular disorders |
|
| Peripheral artery stenosis | Vascular disorders |
|
| Peripheral artery thrombosis | Vascular disorders |
|
| Peripheral embolism | Vascular disorders |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |